Senior Product Management Support I

Goldbelt, Inc.; Frederick (MD); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid time off

Professional development

Job summary

Goldbelt Apex, part of the Healthcare Technology Transformation Group, is seeking a Senior Product Management Support I to assist in regulatory documentation, clinical program management, and cross-functional coordination across therapeutics and diagnostics.

The role involves FDA/IRB coordination, IPT participation, and IND protocol oversight, with travel up to 20% and a salary range reflected in benefits package.

Qualifications

• Must understand and apply cGCP, cGLP, and cGMP.
• Knowledge of FDA requirements and 21 CFR applicable to IND protocols.
• Knowledge of DoD acquisition, Force Health Protection, and clinical/FDA-regulatory product development.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/review regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.

Skills

Medical product development

FDA-regulated products

IND protocols

Regulatory documentation

Clinical project management

Cross-functional coordination

Job description

Overview

Please note that this position is contingent upon the successful award of a contract currently under bid.

Goldbelt Apex, a part of the Healthcare Technology Transformation Group, is a data-focused company dedicated to process and quality in every aspect. As experts in healthcare IT experts, Apex is committed to building systems for healthcare organizations to seamlessly communicate and exchange data across different systems and devices.

Goldbelt APEX is looking for a Senior Product Management Support I.

Responsibilities

• Support product/project management of therapeutics, prophylactics, diagnostics, investigational products, and clinical protocols.
• Develop/review regulatory documentation.
• Coordinate FDA/IRB activities.
• Participate in and lead IPTs/working groups.
• Support IND product accountability, protocol management, technical reports, training, and stakeholder coordination.

Qualifications

Necessary Skills and Knowledge:

• Medical product development.
• FDA-regulated products and clinical programs.
• IND protocols.
• Regulatory documentation.
• Clinical project/program management.
• Cross-functional stakeholder coordination.

Minimum Qualifications:

• Ability to understand and apply cGCP, cGLP, and cGMP.
• Knowledge of FDA requirements and Title 21 CFR applicable to IND protocols.
• Knowledge of DoD acquisition, Force Health Protection, and clinical/FDA-regulatory product development.
• Travel: Up to 20%

Preferred Qualifications:

• Current FHP incumbent.
• DHA Office of Regulated Activities experience.
• IND product/protocol management experience.
• IRB interaction/approval experience.
• Military medical countermeasure experience.
• CONUS/OCONUS operational support experience.

Pay and Benefits

The annual salary for this position is $95,000 to $125,000.

At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.